San Sebastian De Los Reyes

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for people with excess body weight and knee osteoarthritis. This Phase 3 study compares NNC0487-0111 to a placebo, a treatment with no active medicine, to see if it helps reduce weight and knee pain. Participants have knee osteoarthritis diagnosed by specific clinical and radiographic criteria and experience ongoing knee pain. Participants receive weekly injections under the skin using a pre-filled pen injector. The injections, either NNC0487-0111 or placebo, are given in the thigh, abdomen, or upper arm. The study treatments include two dose levels of NNC0487-0111. Treatment assignment is randomized and blinded, meaning participants receive either the medicine or placebo by chance, not by choice. During the study, participants will be monitored for changes in body weight and knee pain using a standardized pain questionnaire over about 80 weeks. They will follow specific instructions about pain medication before assessments. Researchers will track treatment effects, safety, and any side effects throughout the study period.

Researchers are evaluating a new medicine called Sofetabart Mipitecan (LY4170156) in adults with certain types of ovarian, peritoneal, and fallopian tube cancers. This phase 3 study has two parts: Part A focuses on participants whose cancer no longer responds to platinum-based chemotherapy, while Part B includes those whose cancer still responds to platinum-based treatments. The study aims to compare Sofetabart Mipitecan against current standard treatments and to better understand its safety. Participants receive treatments administered through intravenous (IV) infusions. In Part A, Sofetabart Mipitecan is compared with various chemotherapy drugs or mirvetuximab soravtansine. In Part B, Sofetabart Mipitecan combined with bevacizumab is compared with platinum-based chemotherapy plus bevacizumab. Each participant's time in the study depends on how they respond to the treatment. During the study, researchers monitor participants for progression-free survival, measuring the time from randomization until cancer progression or death, for up to 70 months. Participants undergo assessments including scans to track tumor changes and evaluations of safety and side effects. The study collects tumor tissue samples and monitors participants' health status regularly to understand treatment effects and safety over time.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are evaluating how inflammatory bowel disease (IBD) activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study also aims to understand how frailty influences the risk of hospitalization and death in this population. The study seeks to determine if frailty and its related complications can be reversed with proactive treatment and which frailty index best predicts these risks in patients with active IBD. At the start of the study, four clinical frailty indices will be calculated along with clinical information about IBD, including diagnosis, disease characteristics, treatments, and comorbidities. Patients will be followed for 12 months with three visits at 3, 6, and 12 months. During these visits, frailty, comorbidities, disease activity, changes in medical treatments, adverse effects, hospitalizations, and mortality will be reassessed to monitor progress and outcomes. Participants will have detailed assessments including frailty scales and clinical data collection at the beginning and during follow-up visits. Researchers will track hospitalizations and mortality over the year-long period. This monitoring will help evaluate the impact of both IBD activity and frailty on patient health outcomes in a real-world setting.

Researchers are studying patients diagnosed with cancer who experience a venous or arterial thromboembolic event, either symptomatic or found incidentally. These events may occur within a month before the cancer diagnosis or at any time after it. This observational, epidemiological, multicenter study aims to gather detailed data about these thromboembolic episodes in cancer patients. The study does not involve any interventions or treatments but collects information about the thromboembolic event, including its location, vessel of origin, diagnosis type, and characteristics of cancer at the time of the event. It also records the timing between cancer diagnosis and the thromboembolism. Participants are observed over time, with data collected at baseline and a 12-month follow-up visit to assess patient status and treatment details. Participants provide consent and undergo imaging confirmation of thromboembolic events using techniques like Doppler echocardiography or CT angiography. Researchers track multiple outcome measures such as tumor classification, primary tumor presence, and treatment administered for cancer. The study monitors participants for a year to record their clinical situation and gather comprehensive information on cancer-associated thrombosis.

Researchers are evaluating the safety and tolerability of tarperprumig in adults who have been newly diagnosed with or have relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. This Phase 2 study focuses on participants with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) subtypes, classified according to the 2022 ACR/EULAR criteria, who are considered for treatment with rituximab or cyclophosphamide. Participants must have a positive test for PR3-ANCA or MPO-ANCA antibodies and meet specific disease activity criteria based on the Birmingham Vasculitis Activity Score (BVAS). Participants will be randomly assigned to receive either tarperprumig or a placebo in a double-blind, placebo-controlled, parallel-group setup across multiple centers. The study evaluates the investigational drug tarperprumig against placebo to assess safety and efficacy in the target patient population. Treatment details and dosing schedules are not provided in the available information. Throughout the study, researchers will monitor the number of participants experiencing treatment-emergent adverse events from baseline to week 70. Safety and tolerability will be closely assessed during this period. Participants' health status and response to treatment will be regularly evaluated to determine the treatment effects and monitor any risks associated with tarperprumig.

Researchers are evaluating how anxiety and depression symptoms change over time in adults diagnosed with solid cancers. The study aims to identify factors that might predict these symptom patterns, including sociodemographic traits like age and marital status, clinical details such as tumor location and treatment type, psychological aspects like coping methods and fear of recurrence, as well as levels of physical activity. It also explores how these factors relate to patients' needs for support and the use of psychosocial care services. Participants undergo psychosocial and clinical assessments at three points: at diagnosis or start of treatment, and at 3 and 6 months afterward. These assessments include standardized questionnaires covering psychological symptoms, quality of life, cognitive difficulties, physical activity, nutrition, and support needs. Medical records are reviewed to gather clinical information. There is no experimental treatment involved in the study. Throughout the study, participants provide information through self-report questionnaires, allowing researchers to track changes in anxiety and depression symptoms and other factors over time. The main outcomes focus on symptom levels at diagnosis, and their early and medium-term changes at 3 and 6 months. The study involves adults with confirmed solid cancers who are starting systemic antineoplastic treatment or have advanced disease, with total participation lasting at least 6 months.

Malnutrition is a significant health issue affecting many people, especially those with specific medical conditions like lung cancer, as well as vulnerable groups such as pregnant women and the elderly. Lung cancer is a leading cause of cancer-related death worldwide, with 1.8 million new cases and 1.6 million deaths annually. Researchers aim to develop a precision nutrition recommendation model that fully characterizes the nutritional and metabolic status of lung cancer patients to provide personalized dietary solutions based on each individual's unique features. This approach has not yet been widely applied, especially considering genetics and microbiome factors. This study is a prospective observational research project collecting data from lung cancer patients and healthy volunteers to better understand malnutrition and metabolic health. Participants will not receive any assigned treatments as part of the study. The data collected will include genetic, microbiome, tumor, and metabolic information to evaluate their impact on nutritional status, quality of life, and prognosis. The study is part of the larger MENTORINNG project funded by the HORIZON programme, involving multiple international institutions working together to advance precision nutrition for lung cancer patients. Participants will be monitored from registration up to six months for data collection purposes. Researchers will gather detailed information on nutritional and metabolic health, including quality of life measures and disease progression. This extensive data collection aims to support the development of personalized nutrition models that address complex individual nutritional needs. The study includes both lung cancer patients undergoing various treatments and healthy volunteers without cancer, with attention to safety and health status throughout the observation period.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.